Custom Healthcare Systems recalls surgical gown kits with incorrect sterility packaging that may compromise infection control. Affected kits include specific model numbers and lot numbers.
Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
Custom Healthcare Systems is recalling surgical gown kits that were sealed in Tyvek pouches with incorrect specifications, which could compromise product sterility. This risk could lead to infections during medical procedures if the kits are used without proper sterilization.
The convenience kits were sealed in Tyvek pouches using incorrect specifications, which compromises the product's sterility. This means the surgical gowns and hand towels might not be properly sterile when used in medical procedures, increasing infection risks.
Healthcare workers using these surgical gown kits in medical settings are most at risk. Patients undergoing procedures may also be affected if the kits are used without proper sterility.
Check for model numbers 1231-110XL, 1231-080XL, or 1231-150XL on the kit. Lot number W72118 and expiration date July 1, 2021 are also associated with this recall.
Look for model numbers 1231-110XL, 1231-080XL, or 1231-150XL and lot number W72118 on the kit.
The convenience kits were sealed in Tyvek pouches using incorrect specifications, which compromises product sterility.
Check for model numbers 1231-110XL, 1231-080XL, or 1231-150XL and lot number W72118. If affected, contact Custom Healthcare Systems for further instructions.
The recall is for potential infection risk due to compromised sterility, not direct injury risks.
We’ve drafted a message you can send Custom Healthcare Systems to request your refund or repair — edit it as you like.
Subject: Recall Z-0265-2019 — Custom Healthcare Systems Custom Healthcare Systems Hello, I own a Custom Healthcare Systems that is covered by recall Z-0265-2019 from Custom Healthcare Systems. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
